BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3696159 · Received March 24, 2014

    Report

    Report Number
    3004209178-2014-04920
    Event Type
    Injury
    Date Received
    March 24, 2014
    Report Date
    March 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# V053074, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 64002, LOT# N340418, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN ORIGINATING FROM THE STIMULATOR AND NUMBNESS FROM HER LEFT SHOULDER DOWN THE LEFT SIDE OF HER BODY. THE PATIENT STATED THAT THIS STARTED A COUPLE OF WEEKS PRIOR TO THE REPORT. THE PATIENT NOTED THAT SHE HAD A FALL, ACCIDENT, OR TRAUMA AT THAT TIME. THE PATIENT STATED THAT THE FEELINGS DID NOT GO AWAY WHEN SHE DECREASED STIMULATION AND SHE HAD NOT TRIED TURNING STIMULATION OFF. A WEEK LATER, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAINFUL PARASTHESIAS RADIATING FROM HER LEFT CHEST WALL IMPLANTABLE NEUROSTIMULATOR (INS) INTO HER SHOULDER AND NECK FOR SEVERAL WEEKS. THE PAIN RANGES FROM TWO TO EIGHT ON A TEN POINT SCALE. THE PARASTHESIAS WERE PAROXYSMAL AND USUALLY LASTED FOR LESS THAN A MINUTE AND OCCUR MANY TIMES PER HOUR. HOWEVER, THE PATIENT DID ENJOY OCCASIONAL PAIN FREE PERIODS THAT LASTED FOR SEVERAL HOURS. THE PATIENT¿S WHITE BLOOD CELL COUNT, C-REACTIVE PROTEIN, AND SED RATE WERE ALL NORMAL. THERE WAS NO ERYTHEMA OR FLUID COLLECTION AROUND THE INS. THERE WAS SLIGHT TENDERNESS ALONG THE UPPER MARGIN OF THE INS NEAR THE CONNECTORS. THERE WAS NO OPEN OR SHORT CIRCUIT AND NO SIGNIFICANT CHANGES IN THE PAIN WITH THE INS TURNED OFF AND VOLTAGES SET TO ZERO. LATER THAT DAY, IT WAS REPORTED THAT THE PATIENT WAS COMING TO CLINIC ¿ON (B)(6).¿ THE FOLLOWING DAY, IT WAS REPORTED THAT THE PATIENT HAD PAIN AT HER LEFT SIDE IMPLANT. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SCHEDULED REVISION WAS COMPLETED. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS MOVED FROM THE LEFT CHEST AREA TO HER LEFT ABDOMINAL AREA. THE REPORTER STATED THAT IT MAY BE WEEKS BEFORE THEY COULD ACCURATELY GAIN INSIGHT INTO THE RESULTS OF THE PROCEDURE. LATER THAT DAY IT WAS REPORTED THAT IT WAS UNKNOWN IF THE NEW INS POSITION WAS MORE COMFORTABLE, BUT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE AN IMPLANTABLE NEUROSTIMULATOR (INS) POCKET REVISION ON (B)(6) 2014. THE INS WOULD BE MOVED FROM THE PATIENT'S CHEST TO HER ABDOMEN IN AN EFFORT TO MITIGATE THE ONGOING DISCOMFORT ISSUES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPORTER INQUIRED ABOUT THE STATUS OF THE PATIENT ON THE DAY OF THE REPORT. LATER THAT DAY IT WAS REPORTED THAT IT WAS UNKNOWN IF FURTHER DIAGNOSTICS WERE PERFORMED. THE EVENT APPEARED TO HAVE BEEN ONGOING, SPECIFIC TO THE PATIENT¿S DISCOMFORT. NO MALFUNCTIONS WERE SEEN OR THE CAUSE OF THE ISSUE DETERMINED. IT WAS UNKNOWN IF ANY INTERVENTIONS HAD TAKEN PLACE OR BEEN PLANNED. THE PATIENT WAS SCHEDULED TO SEE THE DOCTOR ON (B)(6) 2014 FOR HIS INITIAL CONSULT ON THE MATTER. THE PATIENT WAS STILL RECEIVING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171850 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention